OLYMPUS
OLYMPUS Scopes Duodeno System
TJF-240 and JF-240 EVIS DUODENOVIDEOSCOPE Operation Manual Aug 2006
Operation Manual
76 Pages
Preview
Page 1
INSTRUCTIONS
EVIS DUODENOVIDEOSCOPE
OLYMPUS JF-240 OLYMPUS TJF-240
Refer to the endoscope’s companion manual, the “REPROCESSING MANUAL” whose cover lists the model of your endoscope, for reprocessing information.
Contents
Contents Symbols...
1
Important Information - Please Read Before Use...
2
Intended Use ...
2
Applicability of Endoscopy and Endoscopic Treatment ...
2
Instruction Manual...
3
User Qualifications ...
3
Instrument Compatibility ...
3
Reprocessing and Storage...
4
Spare Equipment ...
4
Repair and Modification ...
4
Signal Words ...
4
Warnings and Cautions ...
5
Chapter 1
Checking the Package Contents...
8
Checking the Package Contents...
8
Instrument Nomenclature and Specifications ...
10
2.1
Nomenclature...
10
2.2
Endoscope Functions ...
12
2.3
Specifications...
14
Preparation and Inspection ...
17
3.1
Preparation of the Equipment ...
18
3.2
Preparation and Inspection of the Endoscope ...
19
3.3
Preparation and Inspection of Accessories...
23
3.4
Attaching Accessories to the Endoscope...
27
3.5
Preparation, Inspection and Connection of the Ancillary Equipment
35
3.6
Inspection of the Endoscopic System ...
37
Operation ...
40
4.1
Insertion ...
42
4.2
Using Endo-Therapy Accessories...
47
4.3
Withdrawal of the Endoscope ...
52
4.4
Transportation of the Endoscope...
52
Troubleshooting ...
54
5.1
Troubleshooting Guide...
54
5.2
Returning the Endoscope for Repair...
58
1.1
Chapter 2
Chapter 3
Chapter 4
Chapter 5
EVIS JF/TJF TYPE 240 Series OPERATION MANUAL
i
Contents
ii
Appendix...
60
System Chart ...
60
EMC information...
67
EVIS JF/TJF TYPE 240 Series OPERATION MANUAL
Symbols
Symbols The meaning(s) of the symbol(s) shown on the package with the components, the back cover of this instruction manual and/or this instrument are as follows:
Refer to instructions.
Endoscope
Type BF applied part
Manufacturer
Authorized representative in the European Community
EVIS JF/TJF TYPE 240 Series OPERATION MANUAL
1
Important Information - Please Read Before Use
Important Information - Please Read Before Use Intended Use These instruments have been designed to be used with an Olympus Video System Center, Light Source, Documentation Equipment, Video Monitor, Endo-Therapy Accessories (such as a Forceps) and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum. Do not use these instruments for any purpose other than their intended uses.
Applicability of Endoscopy and Endoscopic Treatment If there is an official standard on the applicability of endoscopy and endoscopic treatment that is defined by the hospital’s administration or other official institutions such as academic societies on endoscopy, follow that standard. Before starting endoscopy and endoscopic treatment, thoroughly evaluate its properties, purposes, effects, and possible risk (their natures, extent and probability). Perform endoscopy and endoscopic treatment only when its potential benefits are greater than its risks. Fully explain to the patient the potential benefits and risks of the endoscopy and endoscopic treatment as well as any examination/treatment methods that can be performed in its place, and perform the endoscopy and endoscopic treatment only after obtaining the consent of the patient. Even after starting the endoscopy and endoscopic treatment, continue to evaluate the potential benefits and risks, and immediately stop the endoscopy/treatment and take proper measures if the risks to the patient become greater than the potential benefits.
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EVIS JF/TJF TYPE 240 Series OPERATION MANUAL
Important Information - Please Read Before Use
Instruction Manual This instruction manual contains essential information on using this instrument safely and effectively. Before use, thoroughly review this manual and the manuals of all equipment such as the Distal Cover MAJ-311 or MAJ-411 which will be used during the procedure and use the instruments as instructed. Note that the complete instruction manual set for this endoscope consists of this manual and the “REPROCESSING MANUAL” whose cover lists the model of your endoscope. It also accompanied the endoscope at shipment. Keep this and all related instruction manuals in a safe, accessible location. If you have any questions or comments about any information in this manual, please contact Olympus.
User Qualifications The operator of this instrument must be a physician or medical personnel under the supervision of a physician and must have received sufficient training in clinical endoscopic technique. This manual, therefore, does not explain or discuss clinical endoscopic procedures.
Instrument Compatibility Refer to the “System Chart” in Appendix to confirm that this instrument is compatible with the ancillary equipment being used. Using incompatible equipment can result in patient injury or equipment damage. This instrument complies with EMC standard for medical electrical equipment; edition 2 (IEC 60601-1-2: 2001). However, when connected with an instrument that complies with EMC standard for medical electrical equipment; edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1.
EVIS JF/TJF TYPE 240 Series OPERATION MANUAL
3
Important Information - Please Read Before Use
Reprocessing and Storage This instrument was not disinfected or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions in the endoscope’s companion manual, the “REPROCESSING MANUAL” whose cover lists the model of your endoscope. After using this instrument, reprocess and store it according to the instructions in the endoscope’s companion manual, the “REPROCESSING MANUAL” whose cover lists the model of your endoscope. Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage or reduce performance.
Spare Equipment Be sure to prepare another endoscope to avoid that the examination will be interrupted due to equipment failure or malfunction.
Repair and Modification This instrument does not contain any user-serviceable parts. Do not disassemble, modify or attempt to repair it; patient or user injury and/or equipment damage can result. Problems that appear not to be malfunctions may be correctable by referring to Chapter 5, “Troubleshooting”. If the problem cannot be resolved using the information in Chapter 5, contact Olympus.
Signal Words The following signal words are used throughout this manual:
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury.
Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. It may also be used to alert against unsafe practices or potential equipment damage.
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EVIS JF/TJF TYPE 240 Series OPERATION MANUAL
Important Information - Please Read Before Use
Indicates additional helpful information.
Warnings and Cautions Follow the warnings and cautions described below when handling this instrument. This information is supplemented by the warnings and cautions described in each chapter.
•
Never insert or withdraw the endoscope’s Insertion Tube while the Angulation Locks are fixed. Patient injury can result.
•
Do not strike, bend, hit, pull, twist, or drop the endoscope’s Distal End, Insertion Tube, bending section, control section, universal cord, or endoscope connector of the endoscope with excessive force. The endoscope may be damaged and could cause patient injury, burns, bleeding and/or perforations. It could also cause parts of the endoscope to fall off inside the patient.
•
Never perform angulation control forcibly or abruptly. Never forcefully pull, twist or rotate the angulated bending section. Patient injury, bleeding and/or perforation can result. It may also become impossible to straighten the bending section during an examination.
•
Never perform angulation control, air feed control, suction control or insertion/withdrawal of the endoscope’s Insertion Tube without viewing the endoscopic image. Patient injury can result.
•
Do not operate the Bending Section, feed air or apply suction, insert or withdraw the endoscope’s Insertion Tube while the image remains frozen. This could result in patient injury.
•
Never use the endoscope unless the Distal Cover is properly attached to the Distal End. If the Distal Cover is not attached correctly, it may fall off the Distal End during the examination. Continuing the examination after the Distal Cover has fallen off may cause patient injury by the exposed Distal End of the endoscope. It could also result in thermal injury when used in combination with high-frequency Endo-Therapy Accessories.
•
Do not touch the Light Guide immediately after removing it from the Light Source because it is extremely hot.
EVIS JF/TJF TYPE 240 Series OPERATION MANUAL
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Important Information - Please Read Before Use
6
•
Do not twist the Insertion Tube within a narrow tube. This could cause the Distal Cover to come off.
•
Do not pull the Universal Cord. The endoscope’s Light Guide Connector Section will be pulled out from the output socket of the Light Source and the endoscopic image will not be visible.
•
Do not coil the Insertion Tube and a Universal Cord with a diameter of less than 12 cm. Equipment damage can result.
•
To avoid damage to the CCD, do not touch the electrical contacts inside the Electrical Connector.
•
Do not apply shock to the Distal End of the Insertion Tube, particularly the Objective Lens surface of the Distal End. Vision abnormalities may result.
•
Do not twist or bend the Bending Section by hands. Equipment damage may result.
•
Do not squeeze the Bending Section forcefully. The covering of the Bending Section may stretch or break and cause water leaks.
•
Be sure that the Video System Center power switch remains OFF when attaching or detaching the Videoscope Cable from the Electrical Connector. Turn the switch ON or OFF only when the Videoscope Cable is connected to the Video System Center and Electrical Connector of the endoscope. Failure to do this can result in equipment damage, including destruction of the CCD.
•
The endoscope’s Remote Switches cannot be removed from the Control Section. Pulling them with excessive force can break the Remote Switches.
•
If Remote Switch 1 does not return to the OFF position after being pressed strongly from the side, gently tug the switch upwards to return it to the OFF position.
•
Do not press the Remote Switches with undue force as this could cause breakage.
•
Do not hit or bend the Electrical Contacts on the Light Guide Connector Section. The connection to the Light Source may be impaired and faulty contact can result.
EVIS JF/TJF TYPE 240 Series OPERATION MANUAL
Important Information - Please Read Before Use
•
Electromagnetic interference may occur on this instrument near equipment marked with the following symbol or other portable and mobile RF (Radio Frequency) communications equipment such as cellular phones. If electromagnetic interference occurs, mitigation measures may be necessary, such as reorienting or relocating this instrument, or shielding the location.
Details on clinical endoscopic technique are the responsibility of trained specialists. Patient safety in endoscopic examinations and endoscopic treatment can be ensured through appropriate handling by the physician and the medical facility. Examples of inappropriate handling are given below. •
Over-insufflating the lumen may cause patient pain and/or perforation.
•
Using improperly reprocessed or stored instruments may cause patient cross-contamination and infection.
•
Applying prolonged suction with the Distal End in contact with the mucous surface may cause bleeding or suction lesions.
•
Retroflexing the endoscope within the esophagus or duodenal bulb may cause mucous trauma or impaction of the endoscope.
•
Inserting and using Endo-Therapy Accessories without a clear endoscopic image may cause burns or perforation.
•
Patient injury may be caused by; inserting or withdrawing the endoscope, feeding air or applying suction without a clear endoscopic image; withdrawing the endoscope with the angulation controls locked; forcefully pulling, twisting or rotating the angulated Bending Section.
EVIS JF/TJF TYPE 240 Series OPERATION MANUAL
7
Chapter 1 Checking the Package Contents
Chapter 1 Checking the Package Contents 1.1
Checking the Package Contents Match all items in the package with the components shown below. Inspect each item for damage. If the instrument is damaged, a component is missing or you have any questions, do not use the instrument; immediately contact Olympus. This instrument was not disinfected or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions in the endoscope’s companion manual, the “REPROCESSING MANUAL” whose cover lists the model of your endoscope.
8
EVIS JF/TJF TYPE 240 Series OPERATION MANUAL
Chapter 1 Checking the Package Contents
Endoscope
Mouthpiece (MB-142)
Biopsy Valve (MB-358, non-sterile)
Air/Water Valve (MH-438)
Suction Valve (MH-443)
Suction Cleaning Adapter (MH-856)
Washing Tube (MH-974) Distal Cover (MAJ-411, for JF-240 only) (MAJ-311, for TJF-240 only) AW Channel Cleaning Adapter (MH-948)
Channel-opening Cleaning Brush (MH-507)
Water-resistant Cap (MH-553) Channel Cleaning Brush (BW-20T)
Injection Tube (MH-946)
Instruction Manual (Reprocessing)
Instruction Manual (Operation)
Channel Plug (MH-944) Instruction Manual (Distal Cover)
Instructions (Caution for attaching the Distal Cover)
EVIS JF/TJF TYPE 240 Series OPERATION MANUAL
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Chapter 2 Instrument Nomenclature and Specifications
Chapter 2 Instrument Nomenclature and Specifications 2.1
Nomenclature The endoscope’s Main Body is illustrated with its valves and Distal Cover detached.
Venting Connector Water-resistant Cap (MH-553) Universal Cord
Mark 1 13. Suction Connector 16. Electrical Connector
17. S-Cord Connector Mount
Air Pipe
15. Air Supply Connector 15. Water Supply Connector Light Guide
Mark 2 Product Number and Serial Number Electrical Contacts
14. Light Guide Connector Section
10
EVIS JF/TJF TYPE 240 Series OPERATION MANUAL
Chapter 2 Instrument Nomenclature and Specifications
3. UP/DOWN Angulation Lock 1. UP/DOWN Angulation Control Knob
7. Suction Valve (MH-443) Suction Cylinder
6. Air/Water Valve (MH-438)
5. Elevator Control Lever
2. RIGHT/LEFT Angulation Control Knob Control Section
9. Remote Switches
4. RIGHT/LEFT Angulation Lock
Air/Water Cylinder
Grip Section 8. Color Code Yellow: JF-240 Orange: TJF-240
Biopsy Valve (MB-358) <Non-Sterile> 10. Instrument Channel Port
11. Elevator Channel Plug Boot
Working Length
Insertion Tube Limit Mark
Distal Cover (MAJ-411) (for JF-240 only) Distal Cover (MAJ-311) (for TJF-240 only) <Non-Sterile>
Insertion Tube
Distal End 12. Bending Section 9. Remote Switches
EVIS JF/TJF TYPE 240 Series OPERATION MANUAL
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Chapter 2 Instrument Nomenclature and Specifications
2.2
Endoscope Functions 1. UP/DOWN Angulation Control Knob When turned in the “ U” direction, the Bending Section moves UP; when turned in the “D ” direction, the Bending Section moves DOWN. 2. RIGHT/LEFT Angulation Control Knob When turned in the “R ” direction, the Bending Section moves RIGHT; when turned in the “ L” direction, the Bending Section moves LEFT. 3. UP/DOWN Angulation Lock Pushing the lever in the “F ” direction frees angulation. Pushing the lever in the opposite direction locks the Bending Section at any desired position. 4. RIGHT/LEFT Angulation Lock Pushing this lever in the “F ” direction frees angulation. Pushing the lever in the opposite direction locks the Bending Section at any desired position. 5. Elevator Control Lever When this lever is turned in the “ U” direction, the Forceps Elevator is raised. When turned in the opposite direction, the Forceps Elevator is lowered. 6. Air/Water Valve Cover the valve to insufflate air. Depress the valve to feed water for lens washing. If necessary, feed air to remove any remaining fluid or debris adhering to the Objective Lens. 7. Suction Valve Depress the valve to activate suction. Used to remove any fluid and/or debris that obstruct the visual field. 8. Color Code (Yellow: JF-240) (Orange: TJF-240) Used to quickly determine the compatibility of Endo-Therapy Accessories. (The endoscope can be used with Endo-Therapy Accessories that have the same Color Code.) 9. Remote Switches 1 to 4 The functions of the Remote Switches 1 to 4 should be selected on the Video System Center. For selecting the functions, refer to the instruction manual for the Video System Center. 10. Instrument Channel Port Functions as: Channel for the insertion of Endo-Therapy Accessories; Suction Channel; fluid feed channel (from a syringe via the Biopsy Valve).
12
EVIS JF/TJF TYPE 240 Series OPERATION MANUAL
Chapter 2 Instrument Nomenclature and Specifications
11. Elevator Channel Plug To connect the Washing Tube for cleaning and disinfection of Elevator Channel. 12. Bending Section Moves the Distal End of the endoscope by operating the UP/DOWN and RIGHT/LEFT Angulation Control Knobs. 13. Suction Connector Connects to the Suction Tube. 14. Light Guide Connector Section Connects to the output socket of the EVIS Universal Light Source, receives the lamp light from the EVIS Universal Light Source in the Light Guide and transfers the light internally. 15. Water Supply Connector and Air Supply Connector Connects the Water Container’s Water Supply Tube to supply water. 16. Electrical Connector To connect the Videoscope Cable from the EVIS Video System Center. 17. S-Cord Connector Mount Connects to the S-cord to conduct leakage current from the endoscope to the Olympus Electrosurgical Unit. To connect the S-Cord, refer to the instruction manual for the Olympus Electrosurgical Unit.
EVIS JF/TJF TYPE 240 Series OPERATION MANUAL
13
Chapter 2 Instrument Nomenclature and Specifications
2.3
Specifications Environment Operating environment
Transportation and storage environment
14
Ambient temperature
10 – 40°C
Relative humidity
30 – 85%
Atmospheric pressure
700 – 1060 hPa
Ambient temperature
–47 to 70°C
Relative humidity
10 – 95%
Atmospheric pressure
700 – 1060 hPa
EVIS JF/TJF TYPE 240 Series OPERATION MANUAL
Chapter 2 Instrument Nomenclature and Specifications
Specifications Endoscope Functions Model Optical System
JF-240 Field of View Direction of View
100° Backward Sideviewing 15°
Depth of Field Insertion Tube
TJF-240
Distal End Outer Diameter Distal End enlarged
Backward Sideviewing 5° 5 – 60 mm
ø 12.6 mm
ø 13.5 mm
1. Air/Water Nozzle
5. Forceps Elevator
2. Light Guide Lens
6. Hook
3. Objective Lens
7. Elevator Wire
4. Instrument Channel
8. White Ring
6.
2. 3. 1.
5. 7. 4. 8.
Instrument Channel
Insertion Tube Outer Diameter
ø 11.0 mm
ø 12.0 mm
Working Length
1235 mm
1240 mm
Channel Inner Diameter
ø 3.2 mm
ø 4.2 mm
Minimum Visible Distance
10 mm
Direction from which Endo-Therapy Accessories enter and exit the endoscopic image Air Flow Rate
25 cm3/sec Note: Standard when CLV-U40 (high air pressure) is used.
Bending Section Angulation Range Total Length
UP 120°, DOWN 90°, RIGHT 110°, LEFT 90° 1535 mm
EVIS JF/TJF TYPE 240 Series OPERATION MANUAL
1540 mm
15
Chapter 2 Instrument Nomenclature and Specifications
Medical Device Directive
EMC
This device complies with the requirements of Directive 93/42/EEC concerning medical devices. Classification: Class II a Applied standard; IEC 60601-1-2: 2001
This instrument complies with the standards listed in the left column. CISPR 11 of emission: Group 1, Class B This instrument complies with the EMC standard for medical electrical equipment; edition 2 (IEC 60601-1-2: 2001). However, when connecting to an instrument that complies with the EMC standard for medical electrical equipment; edition 1 (IEC 60601-1-2: 1993), the whole system complies with edition 1.
Year of manufacture
2812345 The last digit of the year of manufacture is given in the second digit of the serial number.
Degree of protection against electric shock
16
TYPE BF applied part
EVIS JF/TJF TYPE 240 Series OPERATION MANUAL
Chapter 3 Preparation and Inspection
Chapter 3 Preparation and Inspection •
Before each case, prepare and inspect this instrument as instructed below. Inspect other equipment used with this instrument as instructed in their respective instruction manuals. Should the slightest irregularity be suspected, do not use this instrument and see Chapter 5, “Troubleshooting”. If the irregularity is still suspected after consulting Chapter 5, contact Olympus. Damage or irregularity may compromise patient or user safety and may result in more-severe equipment damage.
•
This instrument was not disinfected or sterilized before shipment. Before using this instrument for the first time, reprocess it according to the instructions in the endoscope’s companion manual, the “REPROCESSING MANUAL” whose cover lists the model of your endoscope.
EVIS JF/TJF TYPE 240 Series OPERATION MANUAL
17